A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of JZP926 in Participants Aged 10 Years and Older for the Treatment of Juvenile Myoclonic Epilepsy
1 other identifier
interventional
260
1 country
10
Brief Summary
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2026
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2026
CompletedFirst Posted
Study publicly available on registry
July 23, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
Study Completion
Last participant's last visit for all outcomes
August 1, 2028
July 24, 2026
July 1, 2026
1.9 years
July 20, 2026
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)
Baseline up to end of 16 weeks treatment period
Secondary Outcomes (9)
Patient and Caregiver Global Impression of Change in Usual Daily Activities (P/CaGI-C UDA) (Part A and Part B)
Week 16
Proportion of participants who achieve ≥ 50% and ≥ 75% reduction from baseline in myoclonic seizure days (Part A and Part B)
Baseline up to end of 16 weeks treatment period
Change from baseline in days with any seizure type per 28 days (Part A and Part B)
Baseline up to end of 16 weeks treatment period
Number of days with fewer myoclonic seizures than participant average prior to entering the study per 28 days (Part A and Part B)
Baseline up to end of 16 weeks treatment period
Percent change from baseline (historical + prospective) in generalized tonic-clonic (GTC) seizure frequency (Part A and Part B)
Baseline up to end of 16 weeks treatment period
- +4 more secondary outcomes
Study Arms (3)
JZP926 Capsule
EXPERIMENTALParticipants with JME will be randomized to JZP926 capsule based on weight-tiered dosing for a 16-week treatment period.
Placebo
PLACEBO COMPARATORParticipants with JME will be randomized to matching placebo based on weight-tiered dosing for a 16-week treatment period.
Open-Label Extension: JZP926 Capsule
EXPERIMENTALParticipants completing Part A or Part B will have the option to continue into an open-label extension for up to 52 weeks, inclusive of a 4 week blinded transition.
Interventions
Oral administration BID according to body weight
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Is ≥ 10 years of age at the time of screening.
- Has a diagnosis of JME per ILAE criteria as specified in the protocol.
- Has at least 4 myoclonic seizure days per 28 days historical seizure frequency.
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Presence of seizure types other than GTC, myoclonic, and absence seizures.
- If historical MRI has been performed, participant's MRI reveals a cause of epilepsy other than JME.
- Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.
- The etiology of the participant's seizures is a progressive neurologic disease.
- Has clinically unstable or progressive epilepsy.
- Has clinically significant unstable medical condition(s), other than epilepsy, including unstable psychiatric disorders.
- Has a history of status epilepticus in the 3 months prior to screening.
- History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on the clinical judgement of the investigator following interview with the participant and/or caregiver.
- Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention.
- Is currently treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening.
- Has a body weight \< 20 kg or \> 150 kg.
- Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to screening.
- Is unwilling or unable to abstain from recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) for the duration of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Clinical Trial Site
New Haven, Connecticut, 06510, United States
Clinical Trial Site
Tampa, Florida, 33609, United States
Clinical Trial Site
Atlanta, Georgia, 30329, United States
Clinical Trial Site
Savannah, Georgia, 31406, United States
Clinical Trial Site
Honolulu, Hawaii, 96817, United States
Clinical Trial Site
Hawthorne, New York, 10532, United States
Clinical Trial Site
Cincinnati, Ohio, 45229, United States
Clinical Trial Site
Portland, Oregon, 97239, United States
Clinical Trial Site
Roanoke, Virginia, 24016, United States
Clinical Trial Site
Winchester, Virginia, 22601, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Part A and Part B are double-blind treatment phases followed by a 52-week open label extension.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2026
First Posted
July 23, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.